Method of manufacturing surgical staples

ABSTRACT

One exemplary process for manufacturing a surgical apparatus may include providing a flat, generally-planar strip of biocompatible material; cutting the strip to produce a feeder belt with at least one lateral edge, and staples affixed to the feeder belt in proximity to at least one lateral edge, where the staples and feeder belt are substantially aligned along a first plane; and bending at least one staple out of the first plane, while the feeder belt remains in the first plane. Another exemplary process for manufacturing a surgical apparatus may include providing a flat, generally-planar strip of biocompatible material; cutting that strip to produce a feeder belt with edges, and staples affixed to different edges of the feeder belt; and coining at least one staple after the cutting.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/048,778 (attorney docket no. 320), filed Mar. 15, 2011, which isherein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention generally relates to surgical staplers and stapling.

BACKGROUND

An endocutter is a surgical tool that staples and cuts tissue totransect that tissue while leaving the cut ends hemostatic. Anendocutter is small enough in diameter for use in minimally invasivesurgery, where access to a surgical site is obtained through a trocar,port, or small incision in the body. A linear cutter is a larger versionof an endocutter, and is used to transect portions of thegastrointestinal tract. A typical endocutter receives at its distal enda disposable single-use cartridge with several rows of staples, andincludes an anvil opposed to the cartridge. The surgeon inserts theendocutter through a trocar or other port or incision in the body,orients the end of the endocutter around the tissue to be transected,and compresses the anvil and cartridge together to clamp the tissue.Then, a row or rows of staples are deployed on either side of thetransection line, and a blade is advanced along the transection line todivide the tissue.

During actuation of an endocutter, the cartridge fires all of thestaples that it holds. In order to deploy more staples, the endocuttermust be moved away from the surgical site and removed from the patient,after which the old cartridge is exchanged for a new cartridge. Theendocutter is then reinserted into the patient. However, it can bedifficult and/or time-consuming to located the surgical site afterreinsertion. Further, the process of removing the endocutter from thepatient after each use, replacing the cartridge, and then finding thesurgical site again is tedious, inconvenient and time-consuming,particularly where a surgical procedure requires multiple uses of theendocutter. That inconvenience may discourage surgeons from using theendocutter for procedures in which use of an endocutter may benefit thepatient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a blank strip.

FIG. 2 is a side view of the blank strip of FIG. 1.

FIG. 3 is a top view of staples affixed to a feeder belt, produced bycutting the blank strip of FIGS. 1-2.

FIG. 4 is a top view of the staples and feeder belt of FIG. 3, afterstaples have been coined.

FIG. 5 is an end view of the staples and feeder belt of FIGS. 3-4, asstaples are bent out of plane relative to the feeder belt.

FIG. 6 is a schematic view of a stamp usable to bend staples relative tothe feeder belt.

FIG. 7 is a flow chart illustrating a method for manufacturing staplesaffixed to a feeder belt.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Referring to FIGS. 1-2, a blank strip 2 is shown. The strip 2 has alength 4, width 6 and height 8. Advantageously, the strip 2 may belonger than illustrated in FIG. 1; the particular length illustrated ischosen for convenience in description. The strip 2 may be substantiallyflat and generally planar, at least in the particular area to be workedas described below. As used in this document, the term “generallyplanar” refers to a strip 2 with a width 6 and length 4 substantiallygreater than its height 8. Alternately, the strip 2 need not begenerally planar, in whole or in part. Optionally, a remainder of thestrip 2 located away from the particular area to be worked as describedbelow may be stored in a reel, for compactness of storage and for easeof feeding the blank 2 into stamps, progressive dies or the like. One ormore alignment apertures 10 may be defined through the strip 2 to ensureregistration of the strip 2 to the machine or machines that act upon thestrip 2. Advantageously, the blank 2 has substantially the same height 8along its length 4. Alternately, the blank 2 may vary in height 8 alongits length 4.

The strip 2 may be composed of any suitable material that isbiocompatible. As one example, the strip 2 may be 316L stainless steel.As another example, the strip 2 may be a different stainless steelalloy. As another example, the strip 2 may be titanium or a titaniumalloy. As another example, the strip 2 may be a polymer such aspolyglycolic acid. As another example, the strip 2 may be a resorbablematerial that gradually dissolves inside the human body. Providing astrip 2 may be a first action 30 in a manufacturing process 40.

The strip 2 may be acted upon by one or more tools to create a finishedset of staples affixed to a staple strip. As one example, the strip 2may be stamped by a set of progressive dies in one or more presses, atone or more stations. As another example, one or more of such stationsmay include a step other than or in addition to stamping, such aslaser-cutting. As another example, the strip 2 may be acted on by one ormore tools, none of which are a die or stamp. For purposes of clarityand brevity, the progressive stamping of the strip 2 is describedherein. A feeding system may push the strip 2 through stations of aprogressive stamping die. Each station may perform one or moreoperations, as described below.

First, referring also to FIGS. 3 and 7, at least a segment of the strip2 is cut to produce a feeder belt 12 integral with and affixed tostaples 14, in a second action 32 in a manufacturing process 40. Thefeeder belt 12 and staples 14 may be configured substantially as setforth in U.S. Patent Application Publication No. 2009/0065552, publishedon Mar. 12, 2009, which is herein incorporated by reference in itsentirety. As one example, at least a segment of the strip 2 is fed intoa first stamping station, and the strip 2 is stamped one or more timesto remove excess material and result in the unitary, flat combination ofthe feeder belt 12 and staples 14 shown in FIG. 3. The staples 14 may begenerally U-shaped, generally V-shaped, or may have any other suitableshape. The staples 14 may be homogeneous in shape, or one or morestaples 14 may be shaped differently from one or more other staples 14.The feeder belt 12 may have two laterally-spaced edges 13, where one ormore staples 14 extend from one or both of those edges 13 of the feederbelt 12. Where the strip 2 is stamped more than once to form the feederbelt 12 and staples 14, the strip 2 may be advanced to a differentstation for one or more of those additional stampings. The apertures 10in the strip 2 may be used to register the strip 2 to each station toensure that the stamping operation at that particular station isperformed on the proper specific part of the strip 2. Registration ofthe strip 2 to a stamping station using apertures 10 in the strip 2 isstandard in the progressive stamping art. Four separate stampings withfour separate dies may be used to produce the feeder belt 12 and staples14 of FIG. 3. Alternately, any suitable number of dies and/or stampingsmay be used to produce the feeder belt 12 and staples 14. At the end ofthe cutting operation, the feeder belt 12 and staples 14 are a singlepart, lying substantially in the plane previously occupied by the strip2 as a whole. Further, the staples 14 and/or feeder belt 12 may remainaffixed to a portion of the strip 2, such as a portion extendinglaterally outward from the staples 14. In this way, the apertures 10 inthe strip 2 still can be used to register the feeder belt 12 and staples14 to the next station, and the strip 2 can be used to move the feederbelt 12 and staples 14 to the next station. That portion of the strip 2is not shown in FIG. 3, for clarity.

Next, referring also to FIG. 4, optionally one or more of the staples 14may be coined in a third action 34 in a manufacturing process 40.“Coining” refers to a form of stamping in which a workpiece is subjectedto a sufficiently high stress to induce plastic flow on the surface ofthe material. The plastic flow may work-harden the area coined, whilethe area not coined retains its toughness and ductility. Coiningcompresses an area of a part through plastic flow, rather than cutting.Where one or more of the staples 14 is coined, that staple or staples 14are coined at and/or near the junction between an end of each staple 14and the feeder belt 12, resulting in a narrow area 16 at and/or near theend of each staple 14 that is affixed to the feeder belt 12. Thenarrowness of the narrow area 16 compared to the width of the adjacentportion of the leg 18 affixed to the feeder belt 12 focuses bending ofthe staple 14 at the narrow area 16 during deployment, and facilitatesshearing of the staple 14 from the feeder belt 12 at the narrow area 16during deployment. The deployment process of a staple 14, and thebending and breaking off of the staple 14 from the feeder belt 12 duringthat deployment process, may be substantially as set forth in U.S.Patent Application Publication No. 2009/0065552. As one example, thestrip 2 is fed into a stamping station in which coining is performed,separate from the first stamping station in which cutting is performed.Two separate stamping operations, with one or more separate dies, may beused to coin one or more staples 14 to form a narrow area 16 on eachsuch coined staple 14. Alternately, a different number of stampingoperations or dies may be used. As another example, the feeder belt 12may be coined adjacent to the connection between the feeder belt 12 andone or more staples 14, instead of or in addition to coining suchstaples 14.

Next, referring also to FIGS. 5-6, at least one staple 14 may be bentout of plane relative to the feeder belt 12 in an action 36 in amanufacturing process 40. As one example, the strip 2 is fed into astamping station in which bending is performed, separate from thestamping station or stations in which cutting is performed, and separatefrom the stamping station or stations in which coining is performed,where coining is performed on one or more staples 14. The feeder belt 12may generally define a plane 18, as described above, where that plane 18may generally bisect the feeder belt 12 into generally-identical upperand lower halves. After the cutting operation described above, and thecoining operation if such coining operation is performed, the staples 14may be substantially aligned along the same plane 18 as the feeder belt12, as seen in FIGS. 3-4. At least one staple 14 may be bent out ofplane 18 relative to the feeder belt 12 to any appropriate angle. Asseen in FIG. 6, at least one staple 14 may be bent at an angle ofsubstantially 90 degrees relative to the feeder belt 12. As anotherexample, one or more staples 14 may be bent to any other suitablenon-zero angle relative to the feeder belt 12. Referring to FIG. 6, asan example of bending, a first die 20 may hold the feeder belt 12, and asecond die 22 may be positioned above the feeder belt 12. The first die20 may have an inverted T-shape as viewed on end, and the second die 22may include a trench 24 or other opening defined therein as viewed onend. The feeder belt 12 may be placed on the platform 26 that definesthe upper surface of the first die 20, at the top of the inverted Tshape. In order to bend one or more staples 14 out of plane relative tothe feeder belt 12, the second die 22 may be moved toward the first die20, which may be fixed. As another example, the first die 20 may bemoved toward the second die 22, which may be fixed. As another example,the first die 20 and the second die 22 may be moved toward one another.Referring also to FIG. 5, as the bottom of the second die 22 adjacent tothe rectangular trench moves downward relative to the first die 20, itcontacts and bends downward at least one staple 14. As the second die 22continues to move downward, it continues to bend one or more staples 14.Referring to FIG. 6, after the second die 22 has stopped movingdownward, one or more of the staples 14 have been bent to a final anglerelative to the feeder belt 12, in which the feeder belt 12 remains inits original, first plane, and at least one staple 14 is aligned along asecond plane different from the first plane. At this time, one or moreof the staples 14 may be positioned against the inner surface of thetrench 24. The trench 24, and the upwardly-extending portion of thefirst die 20, may be sized and shaped such that, in the final positionof the dies 20, 22, the trench 24 and the upwardly-extending portion ofthe first die 20 may be spaced apart from one another a distanceslightly greater than the thickness of a staple 14. A single stampingoperation may be used to bend one or more staples 14 out of planerelative to the feeder belt 12. As another example, two or more stampingoperations, with one or more separate dies, may be used to bend one ormore staples 14 out of plane relative to the feeder belt 12.

At this point, the progressive stamping process is complete. Optionally,the strip 2 may be advanced, and returned to the first stamping stationat which cutting is performed. The steps of cutting, optionally coining,and bending the staples 14 may be repeated on a portion of the strip 2that was not previously stamped. If so, the portion of the strip 2 thathas been stamped may be cut from the remainder of the strip 2, dependingon the length of the strip 2 that has been stamped and the desiredlength of a finished feeder belt 12. This cutting of the portion of thestrip 2 that has been stamped may be a standard cutoff operation asutilized as a final step in progressive stamping.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. It is to be understood that the invention is not limited tothe details of construction, the arrangements of components, and/or themethod set forth in the above description or illustrated in thedrawings. Statements in the abstract of this document, and any summarystatements in this document, are merely exemplary; they are not, andcannot be interpreted as, limiting the scope of the claims. Further, thefigures are merely exemplary and not limiting. Topical headings andsubheadings are for the convenience of the reader only. They should notand cannot be construed to have any substantive significance, meaning orinterpretation, and should not and cannot be deemed to indicate that allof the information relating to any particular topic is to be found underor limited to any particular heading or subheading. Therefore, theinvention is not to be restricted or limited except in accordance withthe following claims and their legal equivalents.

What is claimed is:
 1. A process for manufacturing a surgical apparatus,comprising: separating a feeder belt and a plurality of staples affixedto said feeder belt from a strip of material, said feeder belt and saidplurality of staples lay along a first plane; and bending at least oneof said plurality of staples out of said first plane, while said feederbelt remains in said first plane.
 2. The process of claim 1, whereinsaid separating comprises of cutting, stamping, or coining said strip ofmaterial to separate said feeder belt and said plurality of staples fromsaid strip of material.
 3. The process of claim 2, wherein coining isapplied only to said plurality of staples.
 4. The process of claim 1,wherein said separating comprises of first cutting and then coining toseparate and produce said plurality of staples from said strip ofmaterial.
 5. The process of claim 1, wherein said bending operation isperformed after said separating operation.
 6. The process of claim 1,wherein said bending causes at least one of said plurality of staples tobe bend out of said first plane, while said feeder belt remains in saidfirst plane.
 7. The process of claim 1, wherein separating from saidstrip of material produces said feeder belt with at least one lateraledge.
 8. The process of claim 7, wherein said plurality of staples beingaffixed to said feeder belt at or in proximity to said at least onelateral edge of said feeder belt.
 9. The process of claim 1, whereinsaid plurality of staples affixed to said feeder belt through a narrowstrip of material for each of said plurality of staples.
 10. The processof claim 9, wherein said narrow strip of material allows for a frangibleconnection between each of said plurality of staples affixed to saidfeeder belt.
 11. The process of claim 9, wherein coining is applied tosaid narrow strip of material to allow for a frangible connectionbetween each of said plurality of staples affixed to said feeder belt.12. The process of claim 1, wherein coining is applied to said pluralityof staples for edge hardening of each of said plurality of staples.